E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060707 |
E.1.2 | Term | MALT lymphoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Antitumor activity, in terms of overall response rate (ORR) |
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E.2.2 | Secondary objectives of the trial |
Safety, as acute and long-term toxicity; Response duration (RD) in responders; progression-free survival (PFS) in all patients; Histological response and molecular residual disease (MRD) for gastric MALT lymphoma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extra nodal site • Any stage (Ann Arbor I-IV) • Either de novo, or relapsed/refractory disease following local therapy (including surgery, radiotherapy, and antibiotics for Helicobacter pylori-positive gastric lymphoma) or prior chemotherapy regimen +/- anti-CD20 immunotherapy • No evidence of histologic transformation to a high grade lymphoma • Measurable or evaluable disease • For primary gastric localized Helicobacter pylori-positive disease at diagnosis: 1) persistent disease 1 year after documented Helicobacter pylori infection eradication and 2) clinical, endoscopic (or histologic) evidence of progression at any time after Helicobacter pylori infection eradication • Patient age > 18 years • performance status ECOG <2 • life expectancy of at least 6 months • effective contraception in female pre-menopausal patients • No prior disease of neoplasm within 5 years, except cervical intra-epithelial neoplasia type-1(CIN1) or localized non melanomatous skin cancer • No prior chemotherapy, immunotherapy and radiotherapy in the last 6 weeks • No corticosteroids during the last 28 days unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms • No evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry • No evidence of symptomatic central nervous system (CNS) disease • No impairment of bone marrow function (WBC >3,000/mm3, ANC >1,500/mm3, PLT >100,000/mm3) • No impairment of renal or liver function, unless due to lymphoma involvement • No known HIV infection, no active HBV and/or HCV infection and no evidence of active opportunistic infection • No pregnant or lactating status and appropriate contraceptive method in women of childbearing potential • Appropriate contraceptive method in men • No psychiatric illness precluding understanding concepts of the trial or signing informed consent • The patient has given written informed consent
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E.4 | Principal exclusion criteria |
• Prior autologous or allogeneic SCT or previous organ transplantation • >25% bone marrow infiltration • active auto-immune haemolytic anaemia • participation in another clinical trial during the last 4 weeks • renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma • hepatic insufficiency (transaminase >3-fold of upper normal limit or bilirubin > 2.0 mg/dl), not related to lymphoma • active infection (e.g. HBV, HCV, HIV) • concurrent disease which may hamper the per protocol therapy • severe psychiatric disease or cerebral dysfunction • women during lactation or pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The overall response rate (overall response rate - ORR) at 3 months after Zevalin administration |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |